Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00297284
Status:
TERMINATED
Last Update Posted:
2009-01-28
First Post:
2006-02-24
Brief Title:
Memory and Attention Problems in Lupus New Treatment Trial With Modafinil
Sponsor:
Hospital for Special Surgery New York
Organization:
Hospital for Special Surgery New York
Study Overview
Official Title:
Pilot and Feasibility Study of Modafinil Treatment to Improve Cognitive Efficiency in SLE Patients
Status:
TERMINATED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted in order to determine if the FDA-approved drug Modafinil can improve cognitive function in patients with lupus Modafinil is currently being used to treat excessive sleepiness caused by certain sleep disorders It has also been shown to improve attention and concentration in some people who dont have lupus or sleep disorders This study hopes to determine if Modafinil can be used safely and effectively in lupus patients and improve their quality of life No medications currently exist for the treatment of lupus-associated cognitive dysfunction
Detailed Description:
This is a 6-week pilot and feasibility single-arm open-label trial of modafinil 200mg orally every morning to improve cognitive efficiency in systemic lupus patients with cognitive difficulties in daily life
Cognitive dysfunction is a well-recognized manifestation of systemic lupus erythematosus SLE whose reported prevalence ranges from 12-87 SLE-associated cognitive dysfunction often occurs in the absence of frank neuropsychiatric disease eg stroke depression psychosis cerebral vasculitis medications known to have central nervous system effects or increased disease activity or flare Studies of SLE antibodies most notably the antiphospholipid antibodies have provided conflicting results with respect to their association with SLE-associated cognitive dysfunction Thus despite numerous investigations the etiology of SLE-associated cognitive dysfunction remains unclear There is no known means for preventing cognitive dysfunction in SLE Similarly there are no established or proven treatments for cognitive dysfunction in SLE
Regardless of its cause course or long-term consequences cognitive dysfunction in SLE is a major cause of distress compromised performance of everyday activities and decreased quality of life Thus treatment of decreased cognitive performance in SLE when it occurs no matter how mild and regardless of its potential for permanence or progression is of paramount importance It is imperative to provide SLE patients with cognitive performance difficulties with the means to functionally cope with their impairments so that they can maintain if not regain their independence
Modafinil is a safe orally administered wakefulness-promoting agent approved for use in adults suffering from narcolepsy idiopathic hypersomnia obstructive sleep apnea and shift work sleep syndrome Since its FDA approval it has been used for many additional varied conditions including depression fatigue fibromyalgia myotonic dystrophy organic brain syndrome sleep deprivation Parkinsons and drug-induced somnolence It has also been used in helicopter and airplane pilots to enhance their attentiveness during long flights Some of our SLE patients have been prescribed modafinil for narcolepsy or associated fatigue
Modafinil has broad efficacy in health and illness It enhances cognitive function in normal young adult males as tested by digit span visual pattern recognition memory spatial planning and stop-signal reaction time While the majority of patients prescribed modafinil received the drug for non-cognitive indications eg fatigue sleepiness several have reported improved cognitive function especially with respect to tasks that require attention and concentration
We hypothesize that Modafinil an FDA-approved non-specific wakefulness-promoting agent with minimal side effects is safe and effective when used to improve cognitive efficiency in SLE patients who identify cognitive dysfunction in themselves
Cognitive dysfunction is a well-recognized manifestation of systemic lupus erythematosus SLE whose reported prevalence ranges from 12-87 SLE-associated cognitive dysfunction often occurs in the absence of frank neuropsychiatric disease eg stroke depression psychosis cerebral vasculitis medications known to have central nervous system effects or increased disease activity or flare Studies of SLE antibodies most notably the antiphospholipid antibodies have provided conflicting results with respect to their association with SLE-associated cognitive dysfunction Thus despite numerous investigations the etiology of SLE-associated cognitive dysfunction remains unclear There is no known means for preventing cognitive dysfunction in SLE Similarly there are no established or proven treatments for cognitive dysfunction in SLE
Regardless of its cause course or long-term consequences cognitive dysfunction in SLE is a major cause of distress compromised performance of everyday activities and decreased quality of life Thus treatment of decreased cognitive performance in SLE when it occurs no matter how mild and regardless of its potential for permanence or progression is of paramount importance It is imperative to provide SLE patients with cognitive performance difficulties with the means to functionally cope with their impairments so that they can maintain if not regain their independence
Modafinil is a safe orally administered wakefulness-promoting agent approved for use in adults suffering from narcolepsy idiopathic hypersomnia obstructive sleep apnea and shift work sleep syndrome Since its FDA approval it has been used for many additional varied conditions including depression fatigue fibromyalgia myotonic dystrophy organic brain syndrome sleep deprivation Parkinsons and drug-induced somnolence It has also been used in helicopter and airplane pilots to enhance their attentiveness during long flights Some of our SLE patients have been prescribed modafinil for narcolepsy or associated fatigue
Modafinil has broad efficacy in health and illness It enhances cognitive function in normal young adult males as tested by digit span visual pattern recognition memory spatial planning and stop-signal reaction time While the majority of patients prescribed modafinil received the drug for non-cognitive indications eg fatigue sleepiness several have reported improved cognitive function especially with respect to tasks that require attention and concentration
We hypothesize that Modafinil an FDA-approved non-specific wakefulness-promoting agent with minimal side effects is safe and effective when used to improve cognitive efficiency in SLE patients who identify cognitive dysfunction in themselves
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None